AU2018326894A1 - Production device, system, and method - Google Patents
Production device, system, and method Download PDFInfo
- Publication number
- AU2018326894A1 AU2018326894A1 AU2018326894A AU2018326894A AU2018326894A1 AU 2018326894 A1 AU2018326894 A1 AU 2018326894A1 AU 2018326894 A AU2018326894 A AU 2018326894A AU 2018326894 A AU2018326894 A AU 2018326894A AU 2018326894 A1 AU2018326894 A1 AU 2018326894A1
- Authority
- AU
- Australia
- Prior art keywords
- starting material
- data
- processing
- initial
- analysis
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 112
- 238000000034 method Methods 0.000 title claims description 51
- 238000012545 processing Methods 0.000 claims abstract description 150
- 239000007858 starting material Substances 0.000 claims abstract description 101
- 229940127554 medical product Drugs 0.000 claims abstract description 74
- 238000004458 analytical method Methods 0.000 claims description 122
- 238000007726 management method Methods 0.000 claims description 67
- 210000004027 cell Anatomy 0.000 claims description 45
- 239000013067 intermediate product Substances 0.000 claims description 38
- 238000003860 storage Methods 0.000 claims description 31
- 239000000047 product Substances 0.000 claims description 29
- 238000013461 design Methods 0.000 claims description 17
- 238000004891 communication Methods 0.000 claims description 15
- 230000008569 process Effects 0.000 claims description 15
- 210000004102 animal cell Anatomy 0.000 claims description 14
- 210000005260 human cell Anatomy 0.000 claims description 14
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- 238000012546 transfer Methods 0.000 claims description 5
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- 238000004148 unit process Methods 0.000 claims 1
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- 230000010355 oscillation Effects 0.000 abstract description 13
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- 238000013459 approach Methods 0.000 abstract description 7
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- 230000006870 function Effects 0.000 description 32
- 108090000623 proteins and genes Proteins 0.000 description 18
- 238000010586 diagram Methods 0.000 description 15
- 230000008859 change Effects 0.000 description 13
- 241000700605 Viruses Species 0.000 description 11
- 210000001124 body fluid Anatomy 0.000 description 8
- 239000010839 body fluid Substances 0.000 description 8
- 238000001514 detection method Methods 0.000 description 8
- 238000005259 measurement Methods 0.000 description 8
- 239000002245 particle Substances 0.000 description 8
- 238000000926 separation method Methods 0.000 description 8
- 230000002062 proliferating effect Effects 0.000 description 7
- 230000000735 allogeneic effect Effects 0.000 description 6
- 230000014509 gene expression Effects 0.000 description 6
- 210000004209 hair Anatomy 0.000 description 6
- 238000010801 machine learning Methods 0.000 description 5
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- 238000012371 Aseptic Filling Methods 0.000 description 4
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- 239000000427 antigen Substances 0.000 description 4
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- 239000002904 solvent Substances 0.000 description 4
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- 238000010257 thawing Methods 0.000 description 4
- 239000000654 additive Substances 0.000 description 3
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- 210000004369 blood Anatomy 0.000 description 3
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 239000006185 dispersion Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 239000012467 final product Substances 0.000 description 3
- 238000007710 freezing Methods 0.000 description 3
- 238000005286 illumination Methods 0.000 description 3
- 239000002609 medium Substances 0.000 description 3
- 210000003296 saliva Anatomy 0.000 description 3
- 230000004544 DNA amplification Effects 0.000 description 2
- 238000004364 calculation method Methods 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 238000004108 freeze drying Methods 0.000 description 2
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- 238000001001 laser micro-dissection Methods 0.000 description 2
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- 102000004190 Enzymes Human genes 0.000 description 1
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- 238000009629 microbiological culture Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
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- 238000010948 quality risk assessment Methods 0.000 description 1
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- 229940124597 therapeutic agent Drugs 0.000 description 1
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Classifications
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M21/00—Bioreactors or fermenters specially adapted for specific uses
- C12M21/08—Bioreactors or fermenters specially adapted for specific uses for producing artificial tissue or for ex-vivo cultivation of tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/38—Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M1/00—Apparatus for enzymology or microbiology
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M3/00—Tissue, human, animal or plant cell, or virus culture apparatus
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/30—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration
- C12M41/36—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration of biomass, e.g. colony counters or by turbidity measurements
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q50/00—Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
- G06Q50/10—Services
- G06Q50/22—Social work or social welfare, e.g. community support activities or counselling services
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Zoology (AREA)
- Epidemiology (AREA)
- Public Health (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Wood Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Business, Economics & Management (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Genetics & Genomics (AREA)
- Virology (AREA)
- Primary Health Care (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Microbiology (AREA)
- Sustainable Development (AREA)
- General Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- General Business, Economics & Management (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Tourism & Hospitality (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Botany (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Transplantation (AREA)
- Molecular Biology (AREA)
- Human Resources & Organizations (AREA)
- Theoretical Computer Science (AREA)
- Marketing (AREA)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2017165283 | 2017-08-30 | ||
JP2017-165283 | 2017-08-30 | ||
PCT/JP2018/030656 WO2019044559A1 (ja) | 2017-08-30 | 2018-08-20 | 製造装置、システム及び方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
AU2018326894A1 true AU2018326894A1 (en) | 2020-03-26 |
Family
ID=65527627
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
AU2018326894A Pending AU2018326894A1 (en) | 2017-08-30 | 2018-08-20 | Production device, system, and method |
Country Status (8)
Country | Link |
---|---|
US (2) | US11574709B2 (zh) |
EP (1) | EP3678139A4 (zh) |
JP (2) | JPWO2019044559A1 (zh) |
KR (1) | KR102617342B1 (zh) |
CN (1) | CN111201025B (zh) |
AU (1) | AU2018326894A1 (zh) |
SG (1) | SG11202001704SA (zh) |
WO (1) | WO2019044559A1 (zh) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP7474576B2 (ja) * | 2019-10-04 | 2024-04-25 | 株式会社日立製作所 | 培養装置セットアップ方法、支援装置及び培養装置 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8298054B2 (en) * | 2004-02-03 | 2012-10-30 | Xcellerex, Inc. | System and method for manufacturing |
US7799273B2 (en) * | 2004-05-06 | 2010-09-21 | Smp Logic Systems Llc | Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes |
JP2008271825A (ja) * | 2007-04-27 | 2008-11-13 | Hitachi Plant Technologies Ltd | 培養槽に関する制御因子決定方法及びこれを用いた物質生産方法 |
DE102008013073B4 (de) | 2008-03-06 | 2011-02-03 | Leonhard Kurz Stiftung & Co. Kg | Verfahren zur Herstellung eines Folienelements und Folienelement |
US9069345B2 (en) * | 2009-01-23 | 2015-06-30 | Mks Instruments, Inc. | Controlling a manufacturing process with a multivariate model |
EP2538841A2 (en) * | 2010-02-26 | 2013-01-02 | Myskin, Inc. | Analytic methods of tissue evaluation |
JP2015100309A (ja) * | 2013-11-25 | 2015-06-04 | 東京エレクトロン株式会社 | 自動培養システム及び細胞管理システム |
US10296718B2 (en) * | 2014-05-30 | 2019-05-21 | Hitachi, Ltd. | Medicine production support system and medicine production support method |
GB201501326D0 (en) * | 2015-01-27 | 2015-03-11 | Optimal Ind Automation Ltd | Apparatus and method for use in a process analytical technology system |
CN106591115A (zh) * | 2017-03-02 | 2017-04-26 | 深圳汇创联合自动化控制有限公司 | 一种生物发酵罐在线监测系统 |
-
2018
- 2018-08-20 JP JP2019539371A patent/JPWO2019044559A1/ja active Pending
- 2018-08-20 SG SG11202001704SA patent/SG11202001704SA/en unknown
- 2018-08-20 CN CN201880056485.2A patent/CN111201025B/zh active Active
- 2018-08-20 US US16/643,305 patent/US11574709B2/en active Active
- 2018-08-20 AU AU2018326894A patent/AU2018326894A1/en active Pending
- 2018-08-20 EP EP18850070.6A patent/EP3678139A4/en active Pending
- 2018-08-20 WO PCT/JP2018/030656 patent/WO2019044559A1/ja unknown
- 2018-08-20 KR KR1020207005687A patent/KR102617342B1/ko active IP Right Grant
-
2023
- 2023-01-13 US US18/154,328 patent/US20230162822A1/en active Pending
- 2023-12-26 JP JP2023219520A patent/JP2024038129A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
KR102617342B1 (ko) | 2023-12-27 |
CN111201025A (zh) | 2020-05-26 |
EP3678139A1 (en) | 2020-07-08 |
EP3678139A4 (en) | 2021-06-09 |
JP2024038129A (ja) | 2024-03-19 |
US20230162822A1 (en) | 2023-05-25 |
US20200402621A1 (en) | 2020-12-24 |
US11574709B2 (en) | 2023-02-07 |
WO2019044559A1 (ja) | 2019-03-07 |
CN111201025B (zh) | 2024-04-12 |
KR20200040781A (ko) | 2020-04-20 |
SG11202001704SA (en) | 2020-03-30 |
JPWO2019044559A1 (ja) | 2020-12-24 |
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